COMPANY: Collegium Pharmaceutical, Inc. (www.collegiumpharma.com)
JOB TITLE: Process Development Engineer / Senior Process Development Engineer
LOCATION: Cumberland, RI

JOB DESCRIPTION:
Collegium Pharmaceutical, Inc., a rapidly growing specialty pharmaceutical company, is seeking a Process Development Engineer / Senior Process Development Engineer for our Product Development Team. As a member of our team, you will be working with and learning from experienced pharmaceutical professionals designing, testing and executing small pilot scale manufacturing processes for Collegium’s topical wound care and dermatology products.

JOB REQUIREMENTS:

• B.S. degree or equivalent in chemical engineering, industrial pharmacy or pharmaceutics with 2 – 3 years semi-solid manufacturing process development experience in the pharmaceutical, cosmetic or food industries (Engineer) or B.S. degree or equivalent with 4 – 5 years relevant experience / M.S. degree or equivalent with 1 – 3 years relevant experience (Senior Engineer).
• Proactive, innovative problem solving skills and willing to work “hands on” in the laboratory and manufacturing suite
• Ability to spec-out new manufacturing/filling equipment and identify equipment vendors
• Ability to transfer manufacturing processes between bench, pilot and production scale
• Good knowledge of cGMP rules and regulations and ability to work in cGMP environment
• Highly effective interpersonal, organizational, oral and written communication skills with potential managerial skills to develop and direct staff

JOB RESPONSIBILITIES:

• Conduct design of experiment (DOE) campaigns to develop and test potential manufacturing processes for liquid, gel and other semi-solid formulations
• Assist in the writing of CMC sections for IND, ANDA and NDA submissions of liquid, gel and other semi-solid products
• Write cGMP compliant Master Batch Records based upon the results of process development DOE campaigns
• Work with Manufacturing to implement and test commercial scale manufacturing processes
• Oversee tech transfer of manufacturing and filling processes to contract manufacturing sites